MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INBONE TALAR DOME SZ 1 SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	220220901
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "study: uk infinity® total ankle system subject: (b)(6).Worsening chronic pain medial aspect of right ankle with difficulty mobilizing.In year 2 in 2021, questionnaires stated worsening pain awaiting further decision re-potential revision surgery, possible debridement, or below knee amputation.Awaiting treatment plan.No update as of (b)(6) 2024.Awaiting patient decision re surgery preference as of (b)(6) 2024.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "study: uk infinity® total ankle system subject: 700-017.Worsening chronic pain medial aspect of right ankle with difficulty mobilizing.In year 2 in 2021, questionnaires stated worsening pain awaiting further decision re-potential revision surgery, possible debridement, or below knee amputation.Awaiting treatment plan.No update as of 17 jul 2024.Awaiting patient decision re surgery preference as of (b)(6) 2024.".

• Brand Name: INBONE TALAR DOME SZ 1 SULCUS
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20451694
• Report Number: 3010667733-2024-00752
• Device Sequence Number: 7082229
• Product Code: HSN
• UDI-Device Identifier: 00840420124203
• UDI-Public: 00840420124203
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K133585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 220220901
• Device Lot Number: 1632927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 96 KG